Although the new Drug Price Control Order of 2013 notified last year after a gap of 18 years, the Department of Pharmaceuticals and the patient community soon realized that the Order did not cover many life saving and essential drugs. The price controlled list containing 348 drugs was taken from the National List of Essential Medicines without any detailed consultation of all stakeholders. The whole exercise has been done without assessing its implications on the patient community. Many life saving medicines including anti-cancer drugs, expensive antibiotics and drugs needed for organ transplantation have been left out of price control. In fact, the prices of a number of essential and non essential drugs have gone up after the notification of new DPCO. And the government already admitted this fact in an affidavit filed in court stating that the market value and share of medicines covered by new DPCO is just 18 per cent of the country's pharma market. It is in this context NPPA attempted to invoke a special provision under paragraph 19 of DPCO 2013 empowering it to impose price control on other drugs under extraordinary circumstances and fixed ceiling prices for 108 diabetic and cardiovascular medicines on July 10. Since then the drug companies in the country have been up in arms against the NPPA terming its decision as a retrograde move which will adversely affect the growth of the pharma industry in the country.
NPPA is of the view that there exists a huge inter brand price differences in marketing of branded generics which is indicative of a severe market failure. It felt that different brands of the same drug formulation in the market are having same active ingredients, strength, dosage, route of administration and quality but vary significantly in terms of price. This needs to be corrected. The Department of Pharmaceuticals thus felt it appropriate to rectify this market failure by way of revising the NLEM instead of invoking the special provision in the DPCO. NPPA has thus started an exercise to identify more drugs for the NLEM with a view to ensuring that all lifesaving and essential drugs of mass consumption are included in the revised NLEM for safeguarding the public interest. A detailed analysis of top 300 molecules in terms of moving annual total (MAT) volume and MAT value is being carried out. The issues being looked at include strengths and dosage forms not covered under NLEM 2011. Almost 50 per cent of all drugs marketed in the country today are fixed dose combinations and they are not covered under DPCO. Therefore, the pricing policy followed now undermines the entire objective of making essential drugs affordable to the people. It is important that the price control has to be expanded to cover combinations, additional strengths and dosages of all drugs. All these faults in the current DPCO call for a drastic change by suitably revising NLEM.